BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2161026 · Received June 17, 2011

    Report

    Report Number
    1061932-2011-00603
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    November 14, 2008
    Report Date
    November 14, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS USING CODABAR BARCODE SYMBOLOGY WITHOUT CHECK DIGIT. THE CUSTOMER WAS AWARE THAT NOT USING A CHECKSUM CAN BE A PROBLEM. THE CUSTOMER HAS A PROCEDURE IN PLACE TO CONFIRM THAT THE SAMPLE ID ON THE RESULTS MATCHES THE LABEL ON THE TUBE BEFORE THE RESULTS ARE RELEASED. THIS WAS PERFORMED FOR EACH SAMPLE. ON (B)(4) 2008, THE FIELD SERVICE ENGINEER (FSE) VERIFIED THAT BARCODE SCANNER WAS CLEAN AND READ RATE ACCEPTABLE. NO PROBLEMS WERE OBSERVED. ROOT CAUSE IS FAILURE TO USE A CHECKSUM DIGIT AND THE CHECKSUM FEATURE OF THE COULTER LH 750 HEMATOLOGY ANALYZER. PER LABELING, BECKMAN COULTER STRONGLY RECOMMENDS THE USE OF BAR-CODE CHECKSUMS TO PROVIDE AUTOMATIC CHECKS FOR READ ACCURACY. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A SAMPLE BARCODE MISIDENTIFICATION WHEN USING THE COULTER LH 750 HEMATOLOGY ANALYZER ON (B)(6) 2008. SAMPLE ID (B)(6) WAS INCORRECTLY READ AS (B)(6). A "NO MATCH" ERROR CODE WAS GENERATED. THE SAMPLE BARCODE LABEL WAS READ AGAIN BY THE ANALYZER AND READ CORRECTLY. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LAB. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR